Randomised, Multicenter Phase II Study in Patients With HER-2 Positive Breast Cancer With Capecitabine Versus Observation With Pathologic Residual Tumors After Preoperative Chemotherapy

Shandong Cancer Hospital and Institute0 sites200 target enrollmentOctober 2018

ConditionsHER2-positive Breast Cancer

InterventionsCapecitabine

DrugsCapecitabine

Overview

Phase: Phase 2
Intervention: Capecitabine
Conditions: HER2-positive Breast Cancer
Sponsor: Shandong Cancer Hospital and Institute
Enrollment: 200
Primary Endpoint: disease free survival(DFS)
Status: Not yet recruiting
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

This study is designed to investigate the efficacy and safety of capecitabine, as a postoperative adjuvant chemotherapy, for HER-2 positive breast cancer patients who have pathologic residual cancer cells after the preoperative chemotherapy.

Registry

clinicaltrials.gov

Start Date

October 2018

End Date

December 2025

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Shandong Cancer Hospital and Institute

Responsible Party

Principal Investigator

Zhiyong Yu

Director of the Breast Surgery Ⅰ

Shandong Cancer Hospital and Institute

Eligibility Criteria

Inclusion Criteria

•Female patient with primary, infiltrative breast cancer who has been diagnosed on a histological basis.
•Stage I-IIIB at the first diagnosis and underwent curative resection.
•The patient was non-pCR after preoperative chemotherapy including anthracycline agents; that is, she had undergone primary tumor resection and pathologically confirmed to have residual cancer cells. The previously adminstered preoperative chemotherapy must have involved at least four cycles of anthracycline agents. However, even if anthracycline regimen is shorter than 4 courses, the following regimen can be registered.
•FEC 3 courses (EPI\>=100mg/m2)+Docetaxel 3 courses and trastuzumab 3 courses.
•TCH only over 6 courses
•The patient has been confirmed to be HER2 positive. etc.
•The patient's general performance status is 0 to
•The patient must have no carry-over of efficacy from any previous treatment.
•The patient has maintained sufficient organ function to permit valid evaluation.
•The patient must have no adverse drug reactions of grade 2 or higher carried over from previous treatment.

Exclusion Criteria

•The patient is considered to require postoperative chemotherapy other than capecitabine.
•The patient has previously been treated with oral 5-FU agents (however, previous treatment with iv 5-FU is acceptable).
•The patient has either simultaneous or non-simultaneous bilateral breast cancer.
•The patient has a history of other malignancies or synchronic multiple cancers. However, lesions corresponding to carcinoma in situ or intramucosal carcinoma healed by topical therapy are eligible.
•The patient is pregnant, has the potential and/or wishes to become pregnant, or is breastfeeding.
•The patient has previously had an organ transplant.
•The patient shows hypersensitivity to fluoropyrimidine agents; has previously suffered severe adverse drug reactions with fluoropyrimidine agents; or has a history of serious hypersensitivity to LHRH analogs, tamoxifen, letrozole, anastrozole, and/or exemestane.
•The patient is currently suffering from serious complications or associated disorders, such as malignant hypertension, congestive heart failure, coronary failure, arrhythmias requiring treatment, infectious diseases, and/or hemorrhagic tendency, and/or has suffered a myocardial infarction within the previous 6 months.
•The patient has a fever, and there is the possibility that she has an infection.
•The patient has been shown to have metastasis to other organs.